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Articles 1 - 9 of 9
Full-Text Articles in Law
23andme Inc.: Patent Law And Lifestyle Genetics, Matthew Rimmer
23andme Inc.: Patent Law And Lifestyle Genetics, Matthew Rimmer
Matthew Rimmer
The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology …
Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich
Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich
Janet Freilich
This article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …
Politicizing Patents - Patenting Biotechnology In The Wake Of Section 33, Prometheus, And Cls Bank, Jonathan R. K. Stroud
Politicizing Patents - Patenting Biotechnology In The Wake Of Section 33, Prometheus, And Cls Bank, Jonathan R. K. Stroud
Articles in Law Reviews & Journals
Tucked into the America Invents Act is the first statutory exemption for any patentable subject matter. Section 33 renders unpatentable all claims “encompassing a human being.” By recognizing a vague subject matter – exception for human beings despite the fact that internal policies had long militated against such patent claims, Congress has politicized the patent law to an unheard-of degree. While textually consistent with internal USPTO policy, the passage of § 33 should not be seen as an invitation to litigators to expand § 101 unpatentable-subject-matter challenges to validity by including arguments that medical methods, genetic tests, biological chimeras, or …
Expanding Horizons: Scientific Frontiers, Legal Regulation And Globalization, Belinda Bennett
Expanding Horizons: Scientific Frontiers, Legal Regulation And Globalization, Belinda Bennett
Indiana Journal of Global Legal Studies
In the six decades since the discovery of the double helix structure of DNA by Watson and Crick in 1953, developments in genetic science have transformed our understanding of human health and disease. These developments, along with those in other areas such as computer science, biotechnology, and nanotechnology, have opened exciting new possibilities for the future. In addition, the increasing trend for technologies to converge and build upon each other potentially increases the pace of change, constantly expanding the boundaries of the scientific frontier. At the same time, however, scientific advances are often accompanied by public unease over the potential …
Genomics Unbound: The Bright Future Of Genetic Testing And Therapy In Light Of Prometheus, Fazal Khan, Lindsay Kessler
Genomics Unbound: The Bright Future Of Genetic Testing And Therapy In Light Of Prometheus, Fazal Khan, Lindsay Kessler
Fazal Khan
This article sets out why gene patents are detrimental to society and further explains why the Supreme Court’s decision in Prometheus unfetters the field of genomics from thirty years of bad precedent. Certain vested interests in the biotechnology industry have long argued that gene patents are needed to promote innovation and ultimately benefits the public interest. However, using Myriad’s breast cancer gene patents on BRCA1 and BRCA2 as a case study, this article argues the opposite. Essentially, gene patents stifle research, impede patient access to affordable testing, and set back the development of new therapies. In addition, this article analyzes …
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Patents And Regulatory Exclusivity, Rebecca S. Eisenberg
Book Chapters
This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …
Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd
Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd
Brendan O. Baggot
How can universities make more money with their spinout company (SpinCo)‐suitable technologies? By “growing” their own CEOs to improve both the quality and quantity of startup company leaders available, that’s how. Surprisingly, however, at most universities little or no effort is made to interweave this critical need into tech transfer efforts.
Will Gene Patents Derail The Next-Generation Of Genetic Technologies?: A Reassessment Of The Evidence Suggests Not, Christopher M. Holman
Will Gene Patents Derail The Next-Generation Of Genetic Technologies?: A Reassessment Of The Evidence Suggests Not, Christopher M. Holman
UMKC Law Review
Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that …
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg
Articles
In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years …